6 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·August 21, 2024
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
FDA Enforcement
Class II
·Ongoing·Klinika Mdical Gmb·May 21, 2025
KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
FDA Enforcement
Class II
·Ongoing·Klinika Mdical Gmb·May 21, 2025
Akreos, SKU: AO60P0300. Akreos intraocular lenses
FDA Enforcement
Class III
·Ongoing·Bausch & Lomb Surgical, Inc.·September 3, 2025
Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;
FDA Enforcement
Class I
·Ongoing·Bausch & Lomb Surgical, Inc.·May 14, 2025
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
FDA Enforcement
Class I
·Ongoing·Bausch & Lomb Surgical, Inc.·May 14, 2025